Study to Investigate Pharmacokinetics (PK) of Pramipexole... | NCT02231918

Label	Type	Intervention Names
MIRAPEX® - low	Experimental	Drug: MIRAPEX® - low
MIRAPEX® - medium	Experimental	Drug: MIRAPEX® - medium
MIRAPEX® - high	Experimental	Drug: MIRAPEX® - high

Name	Type	Description	Arm Group Labels	Other Names
MIRAPEX® - low	Drug		MIRAPEX® - low
MIRAPEX® - medium

Measure	Description	Time Frame
Cmax,ss	Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).	0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Cmin,ss	Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).	0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Cpre,N	Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).	0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Cavg	Average concentration of the analyte in plasma at steady state (Cavg).	0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Tmax,ss	Time from dosing to maximum concentration at steady state (Tmax,ss).	0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Tmin,ss	Time from dosing to minimum concentration at steady state (Tmin,ss ).	0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

Measure	Description	Time Frame
Number of Patients With Drug Related Adverse Events	Number of patients with adverse events due to study drug.	From first drug administration until 24 hours after last study drug administration, upto 48 days
Vital Signs (Systolic and Diastolic Blood Pressure)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients ages 6 years to 16 years (two age groups, 6 to 11 years and 12 to 16 years, with the same number of patients if possible)
Diagnosis of idiopathic Restless Legs Syndrome (RLS) according to the Clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG)

All 4 of the following criteria must be present:
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs.)
- The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
- The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
- The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present.)
Must meet all 4 of the diagnostic criteria for adult RLS (see inclusion criterion No. 2 above) and either:
1. The child must be able to describe the leg discomfort in their own words or
2. The child must have 2 or 3 of the following:
  - Sleep disturbance
  - Periodic Limb Movements During Sleep (PLMS) index >5 per hour of sleep, or
  - A biological parent or sibling with definite RLS
Written informed consent consistent with International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) and Local Institutional Review Board requirements for children obtained prior to any study procedures being performed
Ability and willingness to comply with the study treatment regimen and to attend study assessments
Must be on PPX treatment at the same evening maintenance dose for a minimum of 7 days prior to entry into this study as determined by the investigator
A patient who is taking PPX but not as an evening maintenance dose may return for a repeat screening if the patient can be successfully switched and re-stabilized to an evening PPX maintenance dose

Exclusion criteria:

Any women of childbearing potential having a positive serum pregnancy test at screening
Any women of childbearing potential not using a medically accepted method of contraceptive (Intra-Uterine Device, oral, implantable, injectable contraceptives and estrogen patch, double barrier method [spermicide + diaphragm], or abstinence at the discretion of the investigator)
Patients who have a clinically significant renal disease or serum creatinine level greater than 1.0 mg/dL at screening
Any of the following lab results at screening:
- Hemoglobin (Hgb) below the lower limit of normal (LLN), which is determined to be clinically significant
- Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significantly (at the investigator's discretion) out of the normal range at screening (if not caused by substitution therapy according to the investigator's opinion)
- Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator's discretion
Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (such as severe asthma) which in the opinion of the investigator would preclude the patient from participating in this study
History or clinical signs of any neurological disease with potential to secondarily cause RLS symptoms
Presence of any other sleep disorder such as Rapid Eye Movement (REM) sleep behavior disorder, narcolepsy, or sleep apnea syndrome
History of schizophrenia or any psychotic disorder, history of mental disorders, or any present Axis I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) requiring any medical therapy
History of/or clinical signs of epilepsy or seizures other than fever-related seizures in early childhood
History of/or clinical signs of any malignant neoplasm including suspicious undiagnosed skin lesions (which may be melanoma), melanoma, or a history of melanoma
Any other conditions that, in the opinion of the investigator, would interfere with the evaluation of the results or constitute a health hazard for the patient
Allergic response to PPX or the inactive ingredients in its tablet formulation
Had previous treatment with dopamine agonists other than PPX within 14 days prior to the baseline visit
Had any other medical treatment for RLS besides the study medication within 14 days prior to the baseline visit
Had withdrawal symptoms of any medication at screening or at the baseline visit

ID	Title	Description
FG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
FG001	PPX (MIRAPEX®, 0.25 mg)

ID	Title	Description
BG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
BG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
BG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0009 BG00115 BG0022 BG00326

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Cmax,ss

Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Units	Counts
Participants	OG0009 OG00115 OG0022

Title

Denominators

Categories

6 to <12 years (N=5, 9, 0)

Title	Measurements
	OG0000.633± 26.2 OG0011.13± 35.3 OG002NA± NANo patients were recruited for this category.

Primary

Cmin,ss

Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Standard Deviation

ng/mL

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

Cpre,N

Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

Cavg

Average concentration of the analyte in plasma at steady state (Cavg).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

Tmax,ss

Time from dosing to maximum concentration at steady state (Tmax,ss).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Median

Full Range

hours

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Units

Primary

Tmin,ss

Time from dosing to minimum concentration at steady state (Tmin,ss ).

Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Median

Full Range

hours

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Units

Primary

AUCτ,ss

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

λz,ss

Terminal rate constant in plasma at steady state (λz,ss ).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

1/h

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

t1/2,ss

Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

MRTpo,ss

Mean residence time of the analyte in the body at steady state (MRTpo,ss).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

CL/F,ss

Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/min

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

Vz/F,ss

Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

Ae 0-12,ss

Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

12 hours after last study drug administration on day 1

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Units

Primary

fe 0-12,ss

Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

% of PPX excreted

12 hours after last study drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Primary

CLR,ss

Renal clearance of the analyte at steady state (CLR(0-12),ss ).

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/min

12h after last study drug administration on day 1

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Units	Counts

Primary

PTF

Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.

Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

% of PTF

0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Secondary

Number of Patients With Drug Related Adverse Events

Number of patients with adverse events due to study drug.

Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.

Posted

Number

participants

From first drug administration until 24 hours after last study drug administration, upto 48 days

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Units	Counts

Secondary

Vital Signs (Systolic and Diastolic Blood Pressure)

Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).

Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.

Posted

Mean

Standard Deviation

mmHg

-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Secondary

Vital Signs (Pulse Rate)

Vital signs (Pulse rate (both supine and after standing for 1 minute)).

Safety analysis set

Posted

Mean

Standard Deviation

bpm

-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h

ID	Title	Description
OG000	PPX (MIRAPEX®, 0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG001	PPX (MIRAPEX®, 0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
OG002	PPX (MIRAPEX®, 0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.

Units	Counts
Participants

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MEDDRA 10.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected15 at risk EG0021 affected2 at risk
Vomiting	Gastrointestinal disorders	MEDDRA 10.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected15 at risk EG0021 affected2 at risk
Fatigue	General disorders	MEDDRA 10.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected15 at risk EG0020 affected2 at risk
Infusion site erythema	General disorders	MEDDRA 10.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected15 at risk EG0020 affected2 at risk
Infusion site irritation	General disorders	MEDDRA 10.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected15 at risk EG0020 affected2 at risk
Infusion site pain	General disorders	MEDDRA 10.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected15 at risk EG0020 affected2 at risk
Vessel puncture site erythema	General disorders	MEDDRA 10.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected15 at risk EG0020 affected2 at risk
Vessel puncture site pain	General disorders	MEDDRA 10.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected15 at risk EG0020 affected2 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MEDDRA 10.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected15 at risk EG0020 affected2 at risk

ID	Term
D009422	Nervous System Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D020447	Parasomnias
D001523	Mental Disorders

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MIRAPEX® (0.125 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.	9	2	9
EG001	MIRAPEX® (0.25 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.	15	3	15
EG002	MIRAPEX® (0.5 mg)	Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.	2	1	2